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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K000056
Device Name BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
Applicant
Biocell Laboratories, Inc.
2001 University Dr.
Rancho Dominguez,  CA  90220 -6411
Applicant Contact MARC M MCKONIC
Correspondent
Biocell Laboratories, Inc.
2001 University Dr.
Rancho Dominguez,  CA  90220 -6411
Correspondent Contact MARC M MCKONIC
Regulation Number862.1660
Classification Product Code
JJX  
Date Received01/07/2000
Decision Date 02/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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